Z-1087-2007

GE Healthcare Proteus XR/a General Purpose Radiographic System, Models 2259973-4 and 2380179 containing...

Name: Z-1087-2007 GE Healthcare Proteus XR/a General Purpose Radiographic System, Models 2259973-4 and 2380179 containing...
Creator: General Electric Med Systems LLC
Published: 2006-05-31
License: https://open.fda.gov/license/

GE Healthcare / initiated 2006-05-31 / Terminated / root cause: labeling and UDI

FDA source

General Electric Med Systems LLC began a recall of GE Healthcare Proteus XR/a General Purpose Radiographic System, Models 2259973-4 and 2380179 containing Proteus Operator Console model# 2259976 on 2006-05-31. The reason FDA records is "Labeling; failure to properly label per 21 CFR 1010.2 and 1010.3 -The Operator Console of the Proteus XR/a General Purpose Radiographic Systems were not properly labeled". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1087-2007
Status: Terminated
Initiated: 2006-05-31
Posted: 2007-09-25
Terminated: 2007-12-11
Recalling firm: GE Healthcare
Product: GE Healthcare Proteus XR/a General Purpose Radiographic System, Models 2259973-4 and 2380179 containing Proteus Operator Console model# 2259976.
Product code: KPR System, X-Ray, Stationary
Reason for recall: Labeling; failure to properly label per 21 CFR 1010.2 and 1010.3 -The Operator Console of the Proteus XR/a General Purpose Radiographic Systems were not properly labeled.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Consignees were notified of the problem by a visit. To address the Proteus System shipped to the field, a Field Modification (FMI) was created to correct units in the field.
Quantity in commerce: 22 units
Distribution: Nationwide; including states of WA,KS, CO, NM, NC, FL, MT, AZ, TX, IL, NY, MD, and GA
Product codes and lots: 30920HL3, 30921HL1, 31931HL9, 3457OHL2, 34864HL9, 34911HL8, 35136HL1, 35191HL6, 35244HL3, 35936HL4, 36207HL9, 36361HL4, 36431HL5, 36521HL3, 36702HL9, 36704HL5, 37009HL8, 37261HL5, 37395HL1, 37396HL9, 37597HL2 & 993702WK0

Product code KPR

K993090Class IISilhouette FcGe Medical Systems, Inc. / cleared 1999-10-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)